A Phase 4 interventional study of Varenicline in Schizophrenia, Schizoaffective Disorder and Tobacco Smoking, sponsored by Corporal Michael J. Crescenz VA Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-03-22.
Sponsored by Corporal Michael J. Crescenz VA Medical Center · Phase 4, Interventional, and Treatment
To test the feasibility of studying effects of smoking cessation with varenicline on antipsychotic drug-induced neurological side effects, we propose a 12 week pilot study of smoking cessation treatment with varenicline in 10 schizophrenia or schizoaffective disorder patients who are actively smoking and have pre-existing TD while receiving stable doses of antipsychotics. Subjects will be followed after a 2 week baseline period to assess changes in smoking status and neurological symptoms using standardized rating scales. The aim is to examine clinically significant effects on antipsychotic-induced neurological side effects that may warrant further investigation.
At the Screening and Baseline Visits, and at study visits thereafter (Visit 3-7), subjects will be evaluated for efficacy and safety, and changes in smoking or other tobacco use since the last visit. The following measures will be taken; Fagerstrom Test for Cigarette Dependence (FTCD) at screening only; Cigarette smoking will be assessed by a structured questionnaire of time-line follow-back (TLFB) usage; Expired carbon using a hand-held carbon monoxide monitor; Simpson-Angus Scale (SAS), Barnes Akathisia Scale (BAS), and the Abnormal Involuntary Movement Scale (AIMS); Global Clinical Impression Scale (CGI-S at baseline, CGI-I at final visit) for TD; C-SSRS; Brief Psychiatric Rating Scale (BPRS), Mini-Mental Status Examination (MMSE) and Hospital Anxiety and Depression Scale (HADS) at baseline and the final visit only; Brief smoking cessation counseling; Laboratory measures; Urine toxicology sample at the screening and final visits only, serum pregnancy test (women) at screening visit only; Changes in psychotropic medications; Varenicline compliance by pill counts; Adverse events.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 10 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Corporal Michael J. Crescenz VA Medical Center is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FDA-approved indication of varenicline for smoking cessation
Drug: Varenicline
Oral medication approved to facilitate smoking cessation
Also known as: CHANTIX
Self-reported 7-day point prevalence of abstinence prior to week 12
Self-reported 7-day point prevalence of abstinence prior to week 12
Time frame: 12 weeks
A reduction in smoking was determined by a >50% reduction in mean number of cigarettes consumption per day at week 12 compared to baseline
A reduction in smoking was determined by a \>50% reduction in mean number of cigarettes consumption per day at week 12 compared to baseline
Time frame: 12 weeks
Abstinence determined by a CO measure cutoff of ≤ 5 ppm
Abstinence determined by a CO measure cutoff of ≤ 5 ppm
Time frame: 12 weeks
Abstinence determined by 24-hour point prevalence at week 12
Abstinence determined by 24-hour point prevalence at week 12
Time frame: 12 weeks
Percent of subjects showing Clinical Global Impression ratings of at least "much improved"
Percent of subjects showing Clinical Global Impression ratings of at least "much improved"
Time frame: 12 weeks
Percent of patients showing at least 50% improvement in AIMS score,
Percent of patients showing at least 50% improvement in AIMS score,
Time frame: 12 weeks
Mean change in the sum total of score on the AIMS (items 1-7) from the baseline to endpoint visits
Mean change in the sum total of score on the AIMS (items 1-7) from the baseline to endpoint visits
Time frame: 12 weeks
Plan to share: Yes — Final aggregate and pooled data analyses and results devoid of any individual identifying information will be summarized in abstract form for presentations and in a final manuscript for publication at the end of the one-year study period. Final data sets will be shared upon written request for public availability. Data sets meeting VA standards for disclosure to the public will be made available within 1 year of publication. Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access. Guidance on request and distribution processes will be provided by VA ORD. Prior to distribution, a local privacy officer will certify that the data set contains no PHI
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Within one year of publication date and maintained locally until enterprise-level resources become available for long-term storage and access by VA administration.
Access criteria: Final data sets will be shared upon written request for public availability.Guidance on request and distribution processes will be provided by VA ORD. Prior to distribution, a local privacy officer will certify that the data set contains no PHI
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Studies of the drug tested here: Varenicline
Corporal Michael J. Crescenz VA Medical Center